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临床试验/NCT04579965
NCT04579965Unknown不适用

Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele

Mansoura University Hospital0 个研究点目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
postmenstrual spotting.

研究概览

简要总结

Isthmocele is a growing concern as a cause of abnormal uterine bleeding, especially post menstrual bleeding which may be present in up to 82% of these cases (Iannone et al 2019).

our trial is a randomized clinical trial in which women will be randomly allocated to either medical treatment by oral contraceptive or to medical treatment by misotac.

详细描述

Isthmocele is a growing concern as a cause of abnormal uterine bleeding, especially post menstrual bleeding which may be present in up to 82% of these cases There is no universal standard definition of isthmocele but most of the authors agree that isthmocele as a myometrial discontinuity in the myometrium of the anterior uterine wall of >2mm at the site of a cesarean scar in non-pregnant women.

Treatment should be offered only to the symptomatic patient. Surgery, by hysteroscopy, laparoscopy, laparotomy, or vaginal routes, is the most common treatment of choice even in the small defect Surgery is not without complications and many women reject it as a treatment option so it is reasonable to look for medical methods of management.

The pathogenesis of AUB following the development of isthmocele remains unexplained. Oral contraceptive pills might represent a valid option due to a regulatory effect on the endometrium. Several authors describe the effectiveness of oral contraceptives in reducing bleeding disorders correlated to isthmocele.

Another theory of AUB following the development of isthmocele is that menstrual blood can be collected in the defect so that it seeps slowly over the days following menstruation. This mechanism is added by impaired uterine contractility at the scar area.

Misoprostol is a synthetic analog of prostaglandin E1, which increases myometrial contractions so it can be used for various other indications in obstetrics and gynecology the aim is to examine two different methods of medical treatment in cases of symptomatic isthmocele; first regulatory effect on the endometrium (Oral contraceptive pills) and second contraction of myometrium (misotac)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with a previous cesarean section
  • who presented with postmenstrual spotting,
  • sonohysterography had shown a isthmocele

排除标准

  • Pregnancy,
  • (suspected) malignancies,
  • use of any hormonal contraceptives,
  • infection in the genital tract

研究组 & 干预措施

combined contraceptive pills

Other

treat patients with isthmocele with oral contraceptive pills

干预措施: medical treatment of isthmocele (Drug)

Misotac

Other

treat patients with isthmocele with misotac.

干预措施: medical treatment of isthmocele (Drug)

结局指标

主要结局

postmenstrual spotting.

时间窗: after one month of drug treatment

the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle.

次要结局

  • Quality of life, Satisfaction assessed by the VAS(after one month of drug treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Wageh

Alaa Wageh Associate Professor Obstetrics and gynecology

Mansoura University Hospital

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